Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

Rutgers The State University of New Jersey

Status and phase

Enrolling

Phase 2

Conditions

Cardiac Toxicity

Early-stage Breast Cancer

Treatments

Drug: Lipitor 40mg Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT05559164

Pro2022000290 (Other Identifier)

042201

Details and patient eligibility

About

This study proposes that the addition of statins reduces the treatment delays or early discontinuations secondary to cardiotoxicity in patients with Stage I-III HER2 positive breast being treated with anti-HER2 therapy.

Full description

A single arm open-label phase 2 study to evaluate the cardioprotective effects of statins in patients with Stage I-III HER2 positive breast cancer receiving HER2 targeted therapy. This study will evaluate the hypothesis that addition of statins will reduce treatment delays/discontinuations related to symptomatic/asymptomatic cardiac dysfunction in patients being treated with anti-HER2 therapy. The long-term goal of this study is to improve disease related outcomes and quality of life measures in patients being treated with anti-HER2 therapy.

Enrollment

60 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically and/or cytologically confirmed diagnosis of Stage I-III female breast cancer (including inflammatory breast cancer)
Scheduled to receive neoadjuvant/adjuvant HER2 targeted therapy
Between ≥18 years of age
Female patients of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment. Female patients must agree to use effective barrier contraception during the period of therapy
Baseline LVEF ≥ 50%
Prior cancers allowed if no evidence of disease in last 5 years
ECOG 0-2
No prior history of treatment with HER2 targeted therapy or anthracyclines based chemotherapy
Adequate bone marrow function:

I. ANC ≥ 1000/uL II. platelet count ≥ 100,000/uL III. hemoglobin ≥ 9.0 g/dL

• Adequate hepatic function: I. Total bilirubin ≤ 1.5 X ULN II. AST (SGOT) ≤ 5 X ULN III. ALT (SGPT) ≤ 5 X ULN

Adequate renal function, Creatinine < 1.5x institutional ULN or calculated creatinine clearance ≥ 50 mL/min as estimated using the Cockcroft-Gault formula
Ability to understand the nature of this study protocol and give written informed consent
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion criteria

Participants with stage IV breast cancer
Participants currently taking statins
Uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg)
No active liver disease
Current use of CYP 3A4 inhibitors
Any condition including the presence of laboratory abnormalities, which, in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study
Life expectancy < 12 weeks
Pregnancy (positive pregnancy test) or lactation
Pre-existing sensory neuropathy > grade one
Has significant cardiovascular disease, such as:

LVEF < 50% at baseline as assessed by ECHO (preferred) i) Class III or Class IV myocardial disease as described by the New York Heart Association ii) Recent history (within 6 months prior to enrollment) of myocardial infarction; or iii) Symptomatic arrhythmia at the time of randomization

Major surgery without complete recovery in the past four weeks prior to screening
Concurrent active infection
Participant with uncontrolled and/ or active infection with HIV, Hepatitis B or Hepatitis C
Participant who has a history of allergy or hypersensitivity to any of the study drugs
Participant with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonary fibrosis, pulmonary hypersensitivity pneumonitis
Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study